Clinical Trial Finder

Key

Inclusion Criteria:

• - For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.

• - For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.

• - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• - Life expectancy of greater than 12 weeks per the Investigator.

Key

Exclusion Criteria:

• - Impaired cardiac function or history of clinical significant cardiac disease.

• - Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.

• - Active SARS-CoV-2 infection.

• - Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells. This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without daratumumab or rituximab to evaluate the safety, tolerability, and preliminary antitumor activity in patients with relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively. The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase. Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023. Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with daratumumab and advanced NHL in combination with rituximab.

Arms

Experimental: Phase 1: Single Agent IDP-023 - Single Dose

NHL or MM patient treated with a single dose of IDP-023 monotherapy

Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2

NHL and MM patients treated with multiple doses of IDP-023 monotherapy

Experimental: Phase 2: Combination IDP-023 plus rituximab

NHL patients treated with multiple doses of IDP-023 in combination with rituximab

Experimental: Phase 2: Combination IDP-023 plus daratumumab

MM patients treated with multiple doses of IDP-023 in combination with daratumumab

Interventions

Drug: - IDP-023

NK cell therapy

Drug: - Rituximab

Anti-CD20 antibody therapy

Drug: - Daratumumab

Anti-CD38 antibody therapy

Drug: - Interleukin-2

Immune cytokine

Drug: - Cyclophosphamide

Lymphodepleting chemotherapy

Drug: - Fludarabine

Lymphodepleting chemotherapy

Drug: - Mesna

Chemoprotectant